FDA 510(k) Neurology Devices
FDA 510(k) Neurology Devices - Regulatory Overview
FDA 510(k) neurology devices cover diagnostic and therapeutic equipment for the nervous system. The FDA review panel code is NE.
Common categories include:
- EEG and neurophysiology systems - electroencephalographs, EMG, nerve conduction
- Neurostimulators - transcranial magnetic stimulation (TMS), vagus nerve stimulation
- Surgical navigation systems - image-guided neurosurgery platforms
- Intracranial pressure monitors - ICP sensors and drainage systems
- Neuroendoscopes - rigid and flexible scopes for minimally invasive neurosurgery
6334
Total
6279
Cleared
155d
Avg (2y)
1976
Since
6334 Neurology devices
Cleared
Mar 05, 2009
V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
HCG
Device, Neurovascular Embolization
62d
Cleared
Mar 04, 2009
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
JXG
Shunt, Central Nervous System And Components
21d
Cleared
Feb 27, 2009
NIM 3.0
GWF
Stimulator, Electrical, Evoked Response
128d
Cleared
Feb 26, 2009
DX6605E-TENS, DX6605E-G, DX6609-G
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
220d
Cleared
Feb 25, 2009
NAVIGATION PROBES
GZL
Electrode, Depth
188d
Cleared
Feb 20, 2009
SCRAMBLER ST 5 TENS DEVICE
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
294d
Cleared
Feb 20, 2009
ICS CHARTR EP 200
GWJ
Stimulator, Auditory, Evoked Response
95d
Cleared
Feb 20, 2009
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
HAW
Neurological Stereotaxic Instrument
79d
Cleared
Feb 12, 2009
MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
NRY
Catheter, Thrombus Retriever
30d
Cleared
Feb 09, 2009
TENSCARE ITOUCH MODEL(S) EASY AND PLUS
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
175d
Cleared
Feb 05, 2009
TENS-EMS-14
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
118d
Cleared
Jan 30, 2009
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
LIH
Interferential Current Therapy
25d
Cleared
Jan 29, 2009
MAICO MB 11 WITH BERAPHONE PROBE
GWJ
Stimulator, Auditory, Evoked Response
196d
Cleared
Jan 27, 2009
CAMLAB CRANIAL ORTHOSIS HELMET
OAN
Orthosis, Cranial, Laser Scan
217d
Cleared
Jan 23, 2009
PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000
GXY
Electrode, Cutaneous
262d
Cleared
Jan 21, 2009
UNIVERSAL ELECTRODES
GXY
Electrode, Cutaneous
30d
Cleared
Jan 08, 2009
PAIN VISION, MODEL PS-2100
LLN
Device, Vibration Threshold Measurement
457d
Cleared
Jan 06, 2009
ULTIMA FIVE
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
42d
Cleared
Jan 02, 2009
MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL
HCG
Device, Neurovascular Embolization
24d
Cleared
Dec 30, 2008
NICOLET CORTICAL STIMULATOR
GYC
Electrode, Cortical
438d
Cleared
Dec 29, 2008
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
HBF
Drills, Burrs, Trephines & Accessories (compound, Powered)
167d
Cleared
Dec 24, 2008
TWIN NEUROTRAC-III
OMA
Amplitude-integrated Electroencephalograph
204d
Cleared
Dec 22, 2008
CRANIAL PERFORATOR
HBF
Drills, Burrs, Trephines & Accessories (compound, Powered)
103d
Cleared
Dec 16, 2008
BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
OLW
Index-generating Electroencephalograph Software
63d
Cleared
Dec 16, 2008
NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
OBP
Transcranial Magnetic Stimulator
18d
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